Trials / Completed

CompletedNCT00309361

Study of NV-101 for Efficacy, Pharmacodynamics, and Safety in Dental Patients Undergoing Mandibular Procedures

A Phase 3, Multicenter, Randomized, Blinded, Controlled Study of NV-101 for Efficacy, Pharmacodynamics and Safety in Dental Patients Undergoing Mandibular Procedures

Status: Completed
Phase: Phase 3
Study type: Interventional
Enrollment: 240 (planned)

Sponsor: Novalar Pharmaceuticals, Inc. · Industry
Sex: All
Age: 12 Years
Healthy volunteers: Not accepted

Summary

This Phase 3 study is designed as a multicenter, randomized, blinded, controlled study to evaluate the efficacy, pharmacodynamics, and safety of NV-101 administered as a submucosal injection following completion of a restorative or periodontal maintenance procedure requiring local anesthesia with an agent containing a vasoconstrictor. Local vasodilation that results in more rapid clearance of the anesthetic is the proposed mechanism of action.

Conditions

Anesthesia, Dental

Interventions

Type	Name	Description
DRUG	Phentolamine Mesylate (NV-101)

Timeline

Start date: 2006-02-01
Completion: 2006-07-01
First posted: 2006-03-31
Last updated: 2006-11-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00309361. Inclusion in this directory is not an endorsement.